N/A
Completed N=60
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Pregnancy; Habitual Aborter · Weeks of Gestation 37 or More
Source: ClinicalTrials.gov NCT01280357 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM — 84.85 Positive percantage agreement (PPA)
Summary
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM |
84.85 | — |
| PRIMARY The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM |
99.3 | — |
| SECONDARY The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM |
96.61 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant, age 15-40
- Term gestation (>36 completed weeks)
- Singleton fetus
- Active labor
- Vertex presentation
- Requiring internal monitoring
Exclusion Criteria
- Clinical contraindication for Intra Uterine Pressure Catheter
- Major fetal malformation
Data sourced from ClinicalTrials.gov (NCT01280357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.